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RecruitingNCT07394530PPOS-PCOS-IVFUpdated Aug 5, 2026

Comparison of IVF Outcomes Between PPOS and Antagonist Protocols in Women With PCOS

An interventional study of Progestin-Primed Ovarian Stimulation (PPOS) and GnRH Antagonist Protocol in Polycystic Ovary Syndrome (PCOS) and Female Infertility, sponsored by Hanoi General Hospital (Vietnam). Recruiting at 1 site in Vietnam. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-08-05.

Sponsored by Hanoi General Hospital (Vietnam) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

This study aims to compare the outcomes of two ovarian stimulation protocols used in in vitro fertilization (IVF): the progestin-primed ovarian stimulation (PPOS) protocol and the GnRH antagonist protocol.

02

Conditions studied

  • Polycystic Ovary Syndrome (PCOS)
  • Female Infertility
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's planned enrollment of 400 is above the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

This is the only study on the registry with Hanoi General Hospital (Vietnam) as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Women aged 18-40 years
  • Diagnosed with polycystic ovary syndrome (PCOS) according to the modified Rotterdam criteria (2004) (≥2 of 3: oligo/anovulation, hyperandrogenism, or polycystic ovarian morphology on ultrasound)
  • Indicated for in vitro fertilization (IVF) due to PCOS alone or PCOS with other infertility factors (e.g., tubal factor, previous failed IUI)
  • Eligible for controlled ovarian stimulation for IVF
  • Husband/partner with normal sperm parameters or mild to moderate oligoasthenoteratozoospermia (OAT)
  • Willing and able to provide written informed consent and comply with study procedures.

Exclusion criteria

Exclusion Criteria:

  • Uterine abnormalities that may impair implantation or pregnancy outcomes, including congenital uterine malformations, large fibroids distorting the uterine cavity, adenomyosis, or severe intrauterine pathology.
  • History of major ovarian or uterine surgery affecting ovarian reserve or uterine structure (e.g., ovarian cystectomy, endometriosis surgery, myomectomy, unilateral oophorectomy)
  • History of recurrent pregnancy loss (≥3 spontaneous miscarriages)
  • Known chromosomal abnormalities in either partner
  • Inability to adhere to study protocol or follow-up procedures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    PPOS Protocol

    Participants receive ovarian stimulation using the progestin-primed ovarian stimulation (PPOS) protocol for in vitro fertilization.

    Drug: Progestin-Primed Ovarian Stimulation (PPOS)

  • Active comparator
    GnRH Antagonist Protocol

    Participants receive ovarian stimulation using a GnRH antagonist protocol for in vitro fertilization.

    Drug: GnRH Antagonist Protocol

Interventions

  • DrugProgestin-Primed Ovarian Stimulation (PPOS)

    Ovarian stimulation using a progestin-primed ovarian stimulation (PPOS) protocol, including gonadotropins combined with oral progestin for pituitary suppression during in vitro fertilization treatment.

  • DrugGnRH Antagonist Protocol

    Ovarian stimulation using a gonadotropin-releasing hormone (GnRH) antagonist protocol for pituitary suppression during in vitro fertilization treatment.

06

What researchers measure

Primary outcomes

  1. Ongoing pregnancy rate at 12 weeks

    Ongoing pregnancy defined as a viable intrauterine pregnancy with fetal cardiac activity confirmed by ultrasound at or beyond 12 weeks of gestation.

    Time frame: Up to 12 weeks after embryo transfer

Secondary outcomes

  1. Number of Oocytes Retrieved

    Total number of oocytes retrieved per ovarian stimulation cycle at the time of oocyte retrieval

    Time frame: From ovarian stimulation start to oocyte retrieval (approximately 10-14 days)

  2. Number of Mature (MII) Oocytes

    Number of mature oocytes at the metaphase II (MII) stage identified at the time of oocyte retrieval

    Time frame: At the time of oocyte retrieval (approximately 10-14 days after stimulation start)

  3. Live birth rate

    Live birth rate of live-born infants at ≥24 weeks of gestation or with birth weight ≥500 g and signs of life after birth.

    Time frame: Up to delivery (approximately 9-12 months after embryo transfer)

  4. Clinical pregnancy rate

    Clinical pregnancy defined as the presence of a gestational sac with fetal cardiac activity confirmed by ultrasound

    Time frame: 6-7 weeks after embryo transfer

  5. Fertilization Rate

    Fertilization rate, defined as the percentage of fertilized oocytes

    Time frame: 16-18 hours after oocyte insemination

  6. Number of Usable Embryos

    Time frame: From fertilization to embryo assessment (approximately Day 3 to Day 5 after oocyte retrieval).

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07394530
Lead sponsor
Hanoi General Hospital (Vietnam)
Responsible party
Nguyen Duy Phuong (Medical Doctor, Hanoi Medical University) — Principal investigator
First posted
Feb 6, 2026
Start date
Jan 20, 2026
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Aug 5, 2026

Study contacts

Phuong Duy Nguyen, MD, MSc - PI
Contact
nguyenduyphuongncs44@gmail.com
+84 986656835
Anh Huynh Phuong Nguyen, MD, MSc, Study Coordinator
Contact
pn991897@gmail.com
Phuong Duy Nguyen, MD, MS
principal investigator · Hanoi General Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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